BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5147749 · Received October 14, 2015

    Report

    Report Number
    3004209178-2015-20531
    Event Type
    Injury
    Date Received
    October 14, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 17, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011, Z-2276-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4)

    Additional Manufacturer Narrative · 1

    PUMP ANALYSIS RESULTS REVEALED HIGH RESISTANCE IN THE BATTERY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP INDICATED THAT THE GABLOFEN LOT NUMBER WAS NOT KNOWN. THE HCP REPORTED NOT BEING SURE WHAT TROUBLESHOOTING WAS DONE, BUT KNOWING THAT THE ISSUE WAS RESOLVED BECAUSE THE PUMP WAS REPLACED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROVIDER (HCP), REGARDING A 16 YEAR OLD FEMALE PATIENT RECEIVING INTRATHECAL GABLOFEN 2000MCG/ML AT 1246.2MCG/ML VIA AN IMPLANTABLE INFUSION PUMP. THE INDICATION FOR USE OF THE DEVICE WAS FOR INTRACTABLE SPASTICITY AND CEREBRAL PALSY. THE CONCOMITANT MEDICATIONS AND PATIENT HISTORY WERE NOT REPORTED. . IT WAS REPORTED FROM A HEALTHCARE PROVIDER (HCP) THAT THERE WAS EMPTY PUMP ALARM. THE HCP WAS HAVING PROBLEMS UPDATING THE PUMP AND COULD NOT ACCESS THE UPDATE TAB. UPON DIRECTIVES, THE HCP WAS THEN ABLE TO UPDATE THE PUMP. THE PATIENT CHANGED PROVIDERS AND DID NOT GET REFILLED IN TIME AND THE ALARM STARTED A FEW DAYS AGO, APPROXIMATELY ON (B)(6) 2015. THE PATIENT RECENTLY TRANSITIONED HER CARE AND DURING THE TRANSITION THERE WAS A MISCOMMUNICATION. THE LOW RESERVOIR ALARM DATE WAS (B)(6) 2015 AND WAS MISSED. THE EMPTY RESERVOIR ALARM DATE WAS (B)(6) 2015. THE HCP WAS ABLE TO EMERGENTLY REFILL THE PATIENT'S PUMP ON (B)(6) 2015 BECAUSE THEY WERE ABLE TO GET GABLOFEN 2000 MCG/ML ON SHORT NOTICE AND ADMINISTERED AT 1246.2 MCG/ML . THE GABLOFEN LOT NUMBER WAS 2138-105. WHEN REFILLING, THE EXPECTED RESIDUAL VOLUME WAS 0ML, AND THE ACTUAL RESIDUAL WAS A LITTLE LESS THAN 1 ML. THE PATIENT WAS IN WITHDRAWAL THE DAY THE PUMP WAS REFILLED (B)(6) 2015. THE PATIENT HAD BEEN TAKING VALIUM WHEN THE HCP SAW HER AND WAS SLEEPY FROM SELF MEDICATION. AFTER THE REFILL, THE PATIENT'S PUMP WAS RESTARTED AT THE PREVIOUS DOSE AND THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR MONITORING. THE PATIENT WENT INTO AN OVERDOSE ON (B)(6) 2015. THE HCP BELIEVED IT WAS FROM THE ENTERAL TREATMENTS THE PATIENT WAS RECEIVING TO TREAT THE WITHDRAWAL AND THAT A POSSIBLE BOLUS FROM A DURAL POCKET RELEASED (SEE PE (B)(4). THE HCP HAD DECIDED TO REPLACE THE SYSTEM AND WAS CURRENTLY WEANING THE PATIENT FROM BACLOFEN. ON (B)(6) 2015, THE HCP REDUCED THE PATIENT'S DOSE BY 20%. THEY PLAN ON REDUCING IT ANOTHER 20% TODAY TO AROUND 800 MCG/DAY. THE PATIENT WAS BEING MONITORED IN THE INTENSIVE CARE UNIT (ICU) RIGHT NOW AS THEY WERE VERY WORRIED ABOUT THE PATIENT. THE PATIENT OUTCOME AND INTERVENTION REMAINED UNKNOWN AT THE TIME OF THIS EVENT; IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ON 2015-12-18, ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP WHO INITIALLY REPORTED THE EVENT. THE HCP INDICATED THAT SHE FOLLOWED UP WITH THE PATIENT¿S MANAGING HCP AND DISCUSSED THE FACT THAT THE PUMP LOGS INDICATE THAT THE PUMP CONTAINED LIORESAL. THE MANAGING HCP INDICATED THAT THEIR OFFICE ONLY USES GABLOFEN. THE HCP WHO REPORTED THE EVENT STATED THAT THAT IT SOUNDED LIKE THE MANAGING HCP¿S OFFICE MAY NOT BE SURE HOW TO UPDATE THE DRUG NAME AND HADN¿T SINCE FOR THEIR PURPOSES, THE DRUG WAS THE SAME. THE PATIENT HAD ALWAYS HAD GABLOFEN IN HER PUMP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) ON (B)(6) 2015. THE HCP REPORTED THAT THE PATIENT HAD THE PUMP REPLACED DUE TO A LACK OF THERAPEUTIC EFFECT. THEY HAD PERFORMED A PUMP STUDY AND HAD GOOD CEREBROSPINAL FLUID (CSF) FLOW AND A GOOD BLUSH AT THE END OF THE CATHETER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) INDICATED THAT THE PUMP WAS EXPLANTED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678982 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR Hospitalization| L| R